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Study of NTX-253 in Healthy Volunteers and People with Schizophrenia

This study is testing a new investigational drug called NTX-253, given as an oral capsule, in both healthy volunteers and people with stable schizophrenia. Researchers want to understand how safe NTX-253 is, how well your body tolerates it, and how it moves through your system. You could be eligible if you are between 18 and 55 years old. The main goal is to track any side effects (adverse events) that happen during the study. This study is currently unclear in its recruitment status and plans to enroll about 73 participants.

Study design
This is an interventional study with a planned enrollment of 73 participants. It involves giving either NTX-253 or a placebo (an inactive capsule) in single and multiple ascending doses.
What's involved
Participants will receive either a single dose or multiple doses (for 10 consecutive days) of NTX-253 or placebo. Some participants with schizophrenia will have their antipsychotic medication withdrawn for up to 8 days before starting NTX-253.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects from the start of the study until Day 8 after a single dose, Day 17 (for healthy volunteers), or Day 35 (for participants with stable schizophrenia).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07344948

Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia

Recruiting
EARLY_PHASE1Ages 18–55InterventionalTreatment
Neurosterix
~73 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:NTX-253Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of reported Adverse Events
Measured over From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).
+8 more outcomes measured

Conditions

Healthy Participants
Schizophrenia Diagnosis

Explore related trials

Healthy ParticipantsSchizophrenia

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Doug Feltner, MD · STUDY_DIRECTOR · Neurosterix

Who to contact

Doug Feltner, Chief Medical Officer, MD
[email protected]
+41 22 884 15 55
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agrees to use medically acceptable forms of birth control
Part 1 a/b, Part 2 Cohort 7 only: Body mass index (BMI) within the range ≥18.0 to ≤30.0 kg/m2
Participants in the food effect cohort must be willing to eat a single high fat breakfast
(Part 2 only): Stable schizophrenia participants (schizophrenia cohorts only)
Body mass index (BMI) within the range ≥17.5 to ≤36.0 kg/m2
Positive and Negative Syndrome Scale (PANSS) total score \<80 at screening

Exclusion

(Part 1a/b, Part 2 Healthy): History of or current clinically significant medical or mental illness
Cancer diagnosis/treatment in the past 7 years
Acute or chronic gastrointestinal conditions that would interfere with drug tolerance or absorption
Any clinically significant, abnormal 12 lead ECG
Part 2: Any primary DSM-5TR disorder other than schizophrenia
Participants with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history; history of clozapine use.

What this trial measures

  • Number of reported Adverse EventsFrom baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Safety and tolerability will be assessed by the incidence and severity of treatment-emergent adverse events.

  • Number of Adverse Events of Special Interest (AESI)From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Safety and tolerability will be assessed by the incidence and severity of AESIs.

  • Number of dose limiting treatment emergent adverse events (TEAE)From baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Safety and tolerability will be assessed by the incidence and severity of serious or dose limiting TEAEs.

  • Vital Signs: Change in blood pressureFrom baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Blood pressure measurements

  • Vital Signs: Change in temperatureFrom baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Oral temperature measurement

  • Vital Signs: Change in respiratory rateFrom baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Respiratory rate (number of breaths per minute) measurements

  • Vital Signs: Change in heart rateFrom baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Pulse measurements.

  • Change in physical examinationFrom baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Investigator will perform complete physical exam and document any clinically significant conditions.

  • Clinical Laboratory TestsFrom baseline until Day 8 after a single dose, Day 17 (healthy volunteers) or Day 35 (participants with stable schizophrenia).

    Hematology, serum chemistry, urinalysis, and coagulation tests.